- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03743233
Hand and Engine-driven Techniques for Endodontic Retreatment
November 14, 2018 updated by: Maximiliano Sergio Cenci, Federal University of Pelotas
Hand and Engine-driven Techniques for Endodontic Retreatment: Randomized Clinical Trial
Numerous instrumentation techniques have been suggested for the nonsurgical retreatment of teeth with primary failure of endodontic therapy in laboratory studies.
However, there is limited clinical evidence about those different techniques.
The objective of this study is to compare the prevalence and intensity of postoperative pain, as well as the success rate after endodontic retreatment with hand or engine-driven reciprocating instrumentation.
A randomized clinical trial will be performed, considering two comparison groups: hand preparation with stainless steel instruments or engine-driven reciprocating preparation with the Reciproc NiTi System (VDW, Munich, Germany), to verify which technique would lead to lower postoperative pain levels and higher endodontic success rates.
Secondary outcomes related to technique efficiency will be also registered, evaluating the capacity of filling material removal and the time spent on the clinical procedures.
Eighty individuals who need endodontic retreatment in single-rooted teeth will be selected (n=40/group).
Endodontic reintervention will be carried out in two visits.
Periapical radiographs taken after root filling removal protocols will be transferred to an image analysis software.
Then, the percentage of remaining filling material in relation to the total area of the root canal will be evaluated.
The clinical time spent with the removal procedure protocol will be registered, in minutes, by a digital stopwatch.
After each visit, postoperative pain will be assessed using a numerical rating scale.
The record of pain and analgesic drug intake will be performed in 12, 24, 48 hours and 7 days after the clinical procedures.
Success rates will be evaluated after 3, 6, 12 and 24 months, through clinical and radiographic examination, considering the Periapical Index, a 5-point score system.
Data of both groups (percentage of remaining debris, operating time, postoperative pain, clinical and radiographic success) will be analyzed for normality by the Shapiro-Wilk test.
Assuming normal distribution, the data will be compared by t test.
Pearson's correlation coefficient will be applied to detect possible correlations between the evaluated outcomes.
Differences will be considered significant at P=0.05.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Pelotas, RS, Brazil, 96015560
- Recruiting
- Federal University of Pelotas
-
Contact:
- Fernanda G Pappen, PhD
- Phone Number: 53 984033599
- Email: ferpappen@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Good systemic and oral health;
- Requiring root canal retreatment in single-rooted teeth (one root and one root canal);
- Asymptomatic persistent apical periodontitis.
Exclusion Criteria:
- Use of analgesics, anti-inflammatory drugs or other pain modulating drugs;
- Chronic systemic disease (eg: diabetes, hypertension, arthritis and renal dysfunction);
- Systemic disease that could interfere with bone quality;
- Pregnant or breastfeeding women;
- Teeth with untreated periodontal disease;
- Abnormal mobility and with excessively large or curved canals.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hand file instrumentation
|
Reciproc R25 file will be used for gutta-percha removal, until reaching the WL.
The instrument will be introduced into the canal applying slight movements of 3-mm amplitude.
Apical patency will be maintained with a size #15 K-file.
The root canals will be reinstrumented using the Reciproc R50 file.
For both groups, after the root canal filling removal and reinstrumentation protocol, a new radiograph will be taken, without any intracanal instrument, for posterior analysis of the percentage of remaining filling material in the root canal.
If the radiograph demonstrates the persistence of filling material, the technique will be repeated with the last instrument used in the chemomechanical preparation (hand or reciprocating file), also using H-files with circumferential movements against the dentinal walls in order to remove these residual material, followed by abundant irrigation with NaOCl.
|
Active Comparator: Reciprocating instrumentation
|
A crown-down technique will be performed until reaching the provisory WL.
The root canals will be initially deobstructed with size #3 and #2 Gates-Glidden burs (Dentsply-Maillefer) at the coronal and middle root thirds.
Then, hand stainless steel K-files (Dentsply-Maillefer) with decreasing sizes will be used (#40, #35, #30, #25).
The WL will be determined by an electronic apex locator (Novapex; Forum Technologies, Rishon Le-Zion, Israel).
A radiograph will be taken to confirm the WL, which should be 1 mm short of the root apex.
Apical patency will be reached and maintained with a size #15 K-file (Dentsply-Maillefer).
The root canals will be reinstrumented and a size #50 K-file will be standardized as the master apical instrument.
A step-back procedure in 1-mm increments followed until merging with the crown-down rotary enlargement (size #70) will be achieved.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post operative pain
Time Frame: 12, 24, 48 hours and 7 days
|
Change of post operative pain from baseline to 12h, from 12 to 24h, from 24 to 48h and from 48h to 7 days after treatment, assessed using a visual analog scale, where "zero" means no pain and "10" means maximum pain possible
|
12, 24, 48 hours and 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Periapical index
Time Frame: Radiographs will be taken after 3, 6, 12 and 24 months
|
the radiograph will be assessed considering the apex of the tooth and changes occurred after 3, 6, 12 and 24months after treatment
|
Radiographs will be taken after 3, 6, 12 and 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2018
Primary Completion (Anticipated)
November 1, 2019
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
October 16, 2018
First Submitted That Met QC Criteria
November 14, 2018
First Posted (Actual)
November 16, 2018
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
November 14, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPGO027
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
-
Örebro University, SwedenCompletedPostoperative Pain Intensity | Rescue Pain RequirementsSweden
-
Hospital of South West JutlandNovo Nordisk A/SRecruitingPhysical Activity | Postoperative Pain, Acute | Postoperative Pain, Chronic | Bariatric Surgery | MobilizationDenmark
Clinical Trials on Reciprocating
-
University of Sao PauloCompletedEndodontic Treatment of Primary TeethBrazil
-
University of California, San FranciscoCompletedParesthesia | Nerve Injury | Fracture | Surgical Complication | Mandibular Hypoplasia | Mandibular Nerve Injuries | Mandibular Retrognathism | Mandibular Prognathism | Nerve Entrapments | Mandibular HyperplasiaUnited States
-
Bulent Ecevit UniversityCompleted
-
National Taiwan University HospitalNational Science Council, TaiwanUnknownSpinal Muscular Atrophy | Spinal Cord Injury | MyelomeningoceleTaiwan
-
Ain Shams UniversityCompletedPain, Postoperative | Apical Periodontitis | Irreversible PulpitisEgypt
-
Zahedan University of Medical SciencesUnknownPain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms
-
Isparta Military HospitalCompleted
-
University of New MexicoCompletedCancer | Osteoarthritis | Rheumatoid Arthritis | Trauma | Thyroid NoduleUnited States
-
Isparta Military HospitalCompletedApical Periodontitis | Dental Pulp Necrosis | Assessment, PainTurkey